District Court Injunction on ESCs
News is just coming out the the U.S. District Court for D.C. has issued an injunction blocking President Obama’s guidelines for embryonic stem cell research. (If you care to wade through legal opinions, you can click here.)
The plaintiffs represent Nightlight Christian Adoptions and the Christian Medical Association. The defendants are Kathleen Sebelius, NIH and HHS. I am going to do my best to shake the sheen off my new blog and distill down the basics of this decision (here goes nothing):
- In 1996, the Dickey-Wicker Amendment (no giggling) was added to the HHS appropriations bill, where it has stayed for every year since. This amendment prohibits use of federal funds for “(1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero . . .”
- In 1999, NIH declared that funding ESC research was excluded from this statute, because research involving ESCs was inherently separated from isolating the embryos that lead to the cells. Essentially, you can fund the research on the cells, just not the creation of said cells (i.e. destroying embryos).
- In 2001, W’s infamous restrictions on ESC research closed this loophole in the sense that no new derivation of embryonic stem cell lines was allowed to take place if those cells were ever to be fed with medium or serum or whatnot that came from federal funding. (iPSCs are exempt from this rule, btw). The key here was that no downstream research could be carried out on any new cell line, regardless of if it was derived with federal or private money.
- In 2009, President Obama famously reversed the W restrictions by Executive Order No. 13,505, 74 Fed. Reg. 10,667, a number that every school-child is surely taught. This allowed that the NIH “may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem research, to the extent permitted by law.”
- NIH published guidelines in 2009 that laid out several requirements for the derivation of new ESC lines. I won’t re-print them in length here, but they include (IMHO) ample disclosure on the motivation behind donation and plenty of informed consent on the patients’ part.
Essentially, the NIH/Obama position banks on the interpretation that research done on ESC lines is fundamentally separated from the derivation of those lines. In other words, that the Dickey-Wicker amendment does not pertain to the actual research done on derived cell lines because they define it as a separate “piece of research”.
The District Court for D.C. (and Judge Royce Lamberth) cite Random House Dictionary, of all things, to characterize “research” as a singular task that can not be distilled into selective pieces in order to conform (or not conform) to statutes. Judge Lamberth sides with the plaintiffs’ claim that the term “research” as used in Dickey-Wicker Amendment is not an ambiguous term, and that downstream work done on ESCs is essentially inseparable from the derivation of the ESCs with respect to falling under “research”, and is therefore not legal under the 1996 statute.
Speaking of ambiguity, the court makes its position extremely clear with this passage:
ESC research is clearly research in which an embryo is destroyed. To conduct ESC research, ESCs must be derived from an embryo. The process of deriving ESCs from an embryo results in the destruction of the embryo. Thus, ESC research necessarily depends upon the destruction of a human embryo.
That is a crystal-clear equation of downstream research to upstream sourcing of research materials, and possibly brings up ethical dilemmas in other fields.
Where this opinion gets really interesting is where the plaintiffs have made their case for injury. Essentially to get an injunction such as this, they must prove direct and immediate harm to their interests (I am no lawyer, though). The plaintiffs represent financial interests in adult stem cell (ASC) research and applications. They carry this research out under the auspices of two Christian organizations, Nightlight Christian Adoptions and the Christian Medical Association (CMA). They maintain that this new competition for NIH funding (more ESC research) harms their interests because they require the same NIH funding for ASC research. I don’t think anyone following this seriously thinks that this has anything to do with why these particular groups brought suit against NIH, but it had to be proven to gain an injunction all the same.
NIH makes a good case in the end that far more people (researchers and patients) stand to be harmed by the injunction than do if there is no injunction (these specific plaintiffs). However, the court says that the harm to ESC researchers is not significant, as the injunction
“. . . would not interfere with their ability to obtain private funding for their research. In addition, the harm to individuals who suffer from diseases that one day may be treatable as a result of ESC research is speculative. It is not certain whether ESC research will result in new and successful treatments for diseases such as Alzheimer’s and Parkinson’s disease.”
This is an extremely off-base claim, especially in our current economic (and scientific) state, but I will leave it to others to stoke their rage and address it.
Frankly, I am rather shocked that NIH didn’t see this coming, because it seems like a softball in retrospect. I feel that more careful preparation of Obama’s executive order and specifically addressing Dickey-Wicker with a Democratic majority in Congress could have cut much of this off at the pass. As it stands now, two very conservative Christian organizations that happen to engage in scientific research (something in itself that is perfectly acceptable to me), have succeeded in loophole-ing an entire Executive Department into bowing to their will.
Posted on August 23, 2010, in Science Policy, Stem Cells and tagged NIH, stem cells. Bookmark the permalink. 6 Comments.
It should be noted that the district judge originally denied standing (including to parties that wanted to protect embryos) but the court of appeals overturned him in respect to the competition for funds claim (which again he himself originally rejected).
I think it’s a pretty cheesy piece of legal cover, though. If ASC research has independent merit, then it can stand up to NIH peer review against ESCs just like countless other competing fields of research, no? I know it had to be proven to proceed with the injunction, but I think it has the least legs of any part of the case.
I don’t disagree — it just makes the district court judge sound a bit less crazy, since he originally rejected it — he was just not trying to reach out to strike down the law. I honestly don’t know if the appellate panel was more correct on the standing issue. It does sound weak.
I think the case for standing is quite solid and reasonable. However, the judge’s definition of “research” is absurd. As a fellow molecular biologist, I will be forbidden from testing hypotheses generated from private experiments with embryonic stem cells using my own experiments in basic science, for this would be part of the same body of “research.” Under this definition, there is no obvious line across which one body of research becomes another. Thus, the law preventing the NIH from funding “research” of non-US citizens can be extended to prevent the NIH from funding a citizen’s research in a lab shared with non-citizens who benefit from the same body of work.
The fact is that HHS’s definition of “research” has been accepted by Congress, the White House, and the law for over a decade. This opinion’s only an injunction against Obama’s order, but the same logic inevitably leads to banning all embryonic stem cell research including that allowed under GWB’s EO. I think the judge is correct that this injunction does not injure defendants relative to the status quo (so that plank of the ruling is also solid), but clearly this interpretation of the law will injure the defendants greatly once applied more broadly.
This judge’s ignorant dismissal of the obvious (to almost all scientists) meaning of “research” in the statute is a perfect example of why the Chevron standard is applied so often. How many papers in scientific journals include the phrases “in our research,” “in this research,” etc. Any reference to an entire field is always to a “body of research” where the word “research” is implicitly pluralized.
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